International SARS-CoV-2 Infection Observational Study (ICOS) [COVID-19]
Research type
Research Study
Full title
An International Observational Study of Outpatients with SARS-CoV-2 Infection
IRAS ID
283676
Contact name
Sarah Pett
Contact email
Sponsor organisation
Regents of the University of Minnesota
Duration of Study in the UK
1 years, 7 months, 22 days
Research summary
This is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 who have been assessed as not requiring hospitalization (outpatients). \nAdults who seek testing for SARS-CoV-2 will be screened following consent. Those with confirmed SARS-CoV-2 infection will form an observational cohort study and be followed for 28 days. \nThe general aim of this study is to estimate the rate of disease progression for adults who seek testing and test positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. \nSecondary outcomes include participant-reported health status and change in severity of shortness of breath, if participants develop this.\nAs the understanding of the natural history of COVID-19 improves based on this and other studies, inclusion criteria and the data collection plan, including the outcomes assessed in this protocol, may be modified.
REC name
London - City & East Research Ethics Committee
REC reference
20/HRA/2207
Date of REC Opinion
7 May 2020
REC opinion
Favourable Opinion